ADACEL SUMMARY
Adacel®, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.
Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.
The use of Adacel vaccine as a primary series, or to complete the primary series, has not been studied.
Vaccination with Adacel vaccine may not protect all of vaccinated individuals.
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NEWS HIGHLIGHTS
Published Studies Related to Adacel (Tetanus Diphtheria Pertussis Vaccine)
Phase II and III Clinical Studies of Diphtheria-Tetanus-Acellular Pertussis
Vaccine Containing Inactivated Polio Vaccine Derived from Sabin Strains
(DTaP-sIPV). [2013] vaccine (DTaP)... CONCLUSIONS: DTaP-sIPV was shown to be a safe and immunogenic vaccine.
An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. [2011.06.06] Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months.ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.
Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06] BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.
Immunogenicity and safety of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus type b conjugate vaccine when administered concurrently with a pneumococcal conjugate vaccine: a randomized, open-label, phase 3 study. [2011.03.03] A phase 3 randomized, multicenter study evaluated the safety and immunogenicity of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine (DTaP(5)-IPV/Hib) administered at the same visit with 7-valent pneumococcal conjugate vaccine (PCV7, concurrent group) or at separate visits (separated by >/= 15 days; staggered group).
Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China. [2011.02.24] The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim((R))) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib((R))) and IPV (Imovax((R)) Polio) at 3, 4 and 5 months of age (Group C)...
Clinical Trials Related to Adacel (Tetanus Diphtheria Pertussis Vaccine)
Immunogenicity of Adacel� and BOOSTRIX� Vaccines in Adolescents [Completed]
The aim of this study is to describe immunogenicity of a single booster dose of Adacel
vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.
Primary objective:
- To describe seroprotection rates against tetanus and diphtheria in subjects randomized
to receive either Adacel or Boostrix vaccine.
Observational objectives:
- To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean
antibody concentrations (GMCs) in subjects randomized to receive either Adacel or
Boostrix vaccine.
- To describe booster response rates against tetanus, diphtheria, and pertussis in
subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe the rates of adverse events (AEs) immediately post-vaccination, and the
rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with
Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Study of Adacel� Vaccine Administered to Persons 10 Years of Age [Completed]
Immune Responses in Adults to Revaccination With ADACEL� 10 Years After a Previous Dose [Completed]
The purpose of this study is to collect additional immunogenicity and safety data on
re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health
need to establish broader population immunity against pertussis, as well as diphtheria and
tetanus.
Primary Objective:
- To assess immune response to Tdap vaccine (ADACEL®) one month after booster
vaccination.
Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea [Completed]
A Study to Assess the Safety of Adacel® Vaccine [Completed]
The objective of this study is to describe the safety of Adacel® vaccination in adults
subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in
support to Adacel® registration.
Primary objective:
To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after
immunization.
Reports of Suspected Adacel (Tetanus Diphtheria Pertussis Vaccine) Side Effects
Incorrect Route of Drug Administration (5),
Erythema (3),
Fatigue (3),
Pertussis (3),
Inflammation (3),
Open Wound (3),
Cough (3),
Blister (3),
Vaccination Failure (3),
Nasal Congestion (3), more >>
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Page last updated: 2014-11-30
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